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    Summary
    EudraCT Number:2011-003339-74
    Sponsor's Protocol Code Number:
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-08-17
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2011-003339-74
    A.3Full title of the trial
    A Prospective Randomised Controlled Trial of Intravitreal Ozurdex and Macular Laser Therapy versus Macular Laser Therapy only in Diabetic Macular Oedema (OZLASE study)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Prospective Randomised Controlled Trial of Intravitreal Ozurdex and Macular Laser Therapy versus Macular Laser Therapy only in Diabetic Macular Oedema (OZLASE study)
    A.3.2Name or abbreviated title of the trial where available
    OZLASE study
    A.4.1Sponsor's protocol code number
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMoorfields Eye Hospital R&D Department
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAllergan Pharmaceuticals Ltd
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMoorfields Eye Hospital
    B.5.2Functional name of contact pointSue Lydeard
    B.5.3 Address:
    B.5.3.1Street Address162, City Road
    B.5.3.2Town/ cityLondon
    B.5.3.3Post codeEC1V 2PD
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number02075662816
    B.5.5Fax number02075662315
    B.5.6E-mailsue.lydeard@moorfields.nhs.uk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ozurdex
    D.2.1.1.2Name of the Marketing Authorisation holderAllergan Pharmaceuticals Ireland
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameOZURDEX
    D.3.4Pharmaceutical form Implant
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravitreal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDexamethasone
    D.3.9.1CAS number 50-02-2
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number700
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic macular oedema
    E.1.1.1Medical condition in easily understood language
    diabetes related sweeling of the central retina
    E.1.1.2Therapeutic area Diseases [C] - Eye Diseases [C11]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    E.1.2Level PT
    E.1.2Classification code 10025415
    E.1.2Term Macular oedema
    E.1.2System Organ Class 10015919 - Eye disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study the relative efficacy of repeated intravitreal Ozurdex + macular laser therapy versus macular laser therapy only in improving visual acuity and anatomical changes in eyes with diabetic macular oedema (DMO).
    E.2.2Secondary objectives of the trial
    We will also assess whether there is a significant difference in the following outcomes between the two study arms. (1) proportion of subjects who gain ≥10 letters of best corrected visual acuity (BCVA) (2) the proportion of subjects who gain ≥15 letters of BCVA (3) the proportion of subjects who have lost <15 letters (4) the average of the mean change in visual acuity compared to baseline at each intervening timepoint to week 56 (5) mean difference in BCVA letter score between 2 study arms at weeks 24 and 40 (6) the proportion of subjects who have lost ≥ 30 letters (7) mean difference in CST between 2 study arms at week 56 (8) change from baseline in domain scores of the National Eye Institute Visual function questionnaire (VFQ-25) and EQ-5D (9) number of treatments in both arms
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria: 1. Subjects of either sex aged 18 years or over 2. Diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered to be sufficient evidence that diabetes is present: i.Current regular use of insulin for the treatment of diabetes ii.Current regular use of oral anti-hyperglycaemic agents for the treatment of diabetes iii.Documented diabetes by ADA and/or WHO criteria (see Procedures Manual for Diagnosis of Diabetes) 3.Best corrected visual acuity in the study eye between 54 and 78 letters at 1m (ie Snellen VA 6/24 - 6/9) at baseline. 4.On clinical exam, retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield > 300 microns (Spectralis) at baseline. The diabetic macular oedema must be mild to moderate defined as centre involving with a visual acuity of 6/24 - 6/). 5.Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs. 6.Intraocular pressure less than 30 mmHg. 7.Ability to return for study visits 8.Visual acuity in fellow eye ≥ 2/60 9. Ability to give informed consent throughout the duration of the study 10. Previous laser treatment to the macula is not a contraindication to inclusion in the study
    E.4Principal exclusion criteria
    The following exclusions apply to the study eye only (i.e. they may be present for the non study eye, provided that inclusion criterion 8 is met): 1.Macular ischaemia (FAZ > 1000µm in diameter or severe perifoveal intercapillary loss on IVFA). 2.Macular oedema is considered to be due to a cause other than diabetic macular oedema. An eye should not be considered eligible if: (1) the macular oedema is considered to be related to cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities disease (e.g., a taut posterior hyaloid or epiretinal membrane) is the primary cause of the macular oedema. 3.Co-existent ocular disease An ocular condition is present such that, in the opinion of the investigator, visual acuity would not improve from resolution of macular oedema (e.g., foveal atrophy, pigmentary changes, dense subfoveal hard exudates, non retinal conditions, such as amblyopia). 4.An ocular condition is present (other than diabetes) that, in the opinion of the investigator,might affect macular oedema or alter visual acuity during the course of the study (e.g.vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, etc). 5.A substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e., cataract would be reducing acuity to 6/12 or worse if eye was otherwise normal). 6.History of treatment for DMO at any time in the past 3 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment) in the study eye. 7.History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation in the study eye. 8.Anticipated need for PRP in the 6 months following randomisation in the study eye. 9.Proliferative diabetic retinopathy in the study eye. 10.A condition that, in the opinion of the investigator, would preclude participation in the study. 11.Haemoglobin A1c > 11.0 % 12.A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant 13.Blood pressure >170/100 mmHg (i.e. systolic above 170 or diastolic above 100). If blood pressure is brought below 170/100 by anti-hypertensive treatment, subject can become eligible. 14.Major surgery within 28 days prior to randomisation or major surgery planned during the next 12 months at baseline. Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter. 15.Participation in an investigational trial within 30 days of randomisation that involved treatment with any drug that has not received regulatory approval at the time of study entry. Note: subjects cannot receive another investigational drug while participating in the study. 16.Pregnant or lactating women or women intending to become pregnant within the study period including 3 months after study cessation. 17.History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 3 months or anticipated within the next 6 months following randomisation. 18.Aphakia 19.Uncontrolled glaucoma (in investigator’s judgment). 20.Exam evidence of external ocular infection, including conjunctivitis, chalazion, or severe blepharitis. If treated these subjects can be included. 21.Known allergy to fluorescein dye or to any component of the study drug. 22.Fertile male unwilling to use contraception for the duration of the study
    E.5 End points
    E.5.1Primary end point(s)
    Primary endpoint: Difference in mean best corrected ETDRS visual acuity (BCVA) letter score at 56 weeks between the two arms.
    E.5.2Secondary end point(s)
    (1) proportion of subjects who have gained ≥10 letters of BCVA (2) the proportion of subjects who have gained ≥15 letters of BCVA (3) the proportion of subjects who have lost <15 letters (4) the average of the mean change in visual acuity compared to baseline at each intervening timepoint to week 56 (5) mean difference in BCVA letter score between 2 study arms at weeks 24 and 40 (6) the proportion of subjects who have lost ≥ 30 letters (7) mean difference in CST between 2 study arms at week 56 (8) change from baseline in domain scores of the National Eye Institute Visual function questionnaire (VFQ-25) and EQ-5D (9)number of treatments in both arms
    E.5.2.1Timepoint(s) of evaluation of this end point
    All end-points will be at evaluated at 56 weeks. The secondary end point stated in point (5) above is mean difference in BCVA letter score between 2 study arms at weeks 24 and 40. The difference will be only evaluated after end of study (last patient last visit).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Laser treatment (standard care)
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 55
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state80
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Following completion of trial follow-up, subjects will continue to be treated in the Medical Retina Service at Moorfields Eye Hospital. If they have ongoing diabetic macular oedema requiring treatment, they will be able to receive laser treatment for this irrespective of which arm of the trial they had been randomised to. There is no contraindication to receiving laser treatment after Ozurdex therapy. There is no funding in place as part of the trial…..
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2011-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-09-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-22
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